Suturing devices for heart valve surgery

ABSTRACT

Disclosed are devices and methods for delivering several sutures accurately and simultaneously around the perimeter of an annular prosthetic device (prosthetic heart valve, annuloplasty ring, etc.) to secure the prosthetic device within a native heart valve region. Devices can comprise a proximal handle portion including an actuator and a distal suturing portion including several curved and straight needles arrayed around the shaft axis. The straight needles and the curved needles are configured to simultaneously guide a plurality of sutures through the native tissue and through the annular prosthetic device. The actuator can cause the straight needles to move axially relative to the curved needles and can also cause the curved needles to rotate, such that the motions are coordinated to simultaneously place all the sutures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/701,081 filed Dec. 2, 2019, which is a continuation of U.S. patentapplication Ser. No. 15/895,950 filed Feb. 13, 2018, which claims thebenefit of U.S. patent application Ser. No. 62/461,159 filed Feb. 20,2017, the entire disclosures all of which are incorporated by referencefor all purposes.

FIELD

This application is related to devices and methods for suturingprosthetic devices during heart valve surgeries.

BACKGROUND

Prosthetic cardiac valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (such as the aortic,pulmonary and mitral valves) serve critical functions in assuring theforward flow of an adequate supply of blood through the cardiovascularsystem. These heart valves can be rendered less effective by congenital,inflammatory or infectious conditions. Such damage to the valves canresult in serious cardiovascular compromise or death.

Treatments for such disorders include surgical repair or replacement ofthe valve, such as during open heart surgery. In some procedures, a newprosthetic heart valve is sutured within the valve region to replace thefunctionality of the native valve. In other procedures, an annuloplastyring or other device is sutured around the native valve annulus toimprove the functionality of the native valve. In many of thesesurgeries, a series of many sutures need to be placed around theperimeter of the prosthetic device to secure it to the native tissue.

Traditionally, each suture is placed one at a time by a surgeon, whichrequires a lot of time and requires great care and dexterity to ensurethat each suture is secured properly. If any of the sutures come loose,or are too tight or too loose, the patient's health may be jeopardized.At the same time, it is desirable to minimize the duration of thesurgical process to reduce the risks of complications such as infectionand ischemia. Thus, there is a need for devices and methods that enablea prosthetic heart valve device to be sutured in place both more rapidlyand more accurately.

SUMMARY

Disclosed herein are several exemplary suturing device and relatedmethods for delivering several sutures accurately and simultaneouslyaround the perimeter of an annular prosthetic device (e.g., a prostheticheart valve, an annuloplasty ring, or other annular device) to securethe prosthetic device within a native heart valve region. Exemplarysuturing devices can comprise a shaft portion defining a shaft axis, ahandle portion at a proximal end of the shaft portion, the handleportion including an actuator, and a suturing portion at a distal end ofthe shaft portion. The suturing portion includes several curved needlesarrayed around the shaft axis and a corresponding number of straightneedles arrayed around the shaft axis. The straight needles and thecurved needles are configured to guide a plurality of sutures throughthe native tissue and through the annular prosthetic devicesimultaneously. In some embodiments, the actuator causes the straightneedles to move axially relative to the curved needles and also causesthe curved needles to rotate, such that the axial motion of the straightneedles and the rotation of the curved needles are coordinated tosimultaneously place the plurality of sutures that secure the annularprosthetic device within the native heart valve region.

The disclosed device can be used to suture a prosthetic device in any ofthe native heart valve regions, and particularly in the native aorticvalve region. The number of sutures placed by the device can vary fromone or two or three, to 10 or 20 or more. The sutures can be placed inpredetermined locations and spacing around the perimeter of theprosthetic device to secure it in place.

In some embodiments, the straight needles project distally from a firstrigid support plate. The first rigid support place can be mounted arounda distal end of the shaft portion and proximal to the curved needles.The straight needles can penetrate distally into/through the annularprosthetic device (e.g., through a sewing ring of a prosthetic heartvalve) when the actuator causes the straight needles to move axiallyrelative to the curved needles. In some embodiments, the straightneedles comprise hooks or other suture engagement members at theirdistal ends, to allow the straight needs to engage the sutures from thecurved needles and draw the sutures back proximally through the annularprosthetic device.

In some embodiments, the curved needles each project from a differentrespective drive shaft, and the curved needles each rotate about an axisof their own respective drive shaft. The drive shafts can all besupported by a second rigid plate distal to the first rigid plate, suchthat the drive shafts can each rotate about their respective axisrelative to the second rigid plate. The drive shafts can all be engagedto a common central driver (e.g. a sun gear), wherein the central drivercauses all the drive shafts and all the curved needles to rotate at thesame time and same rate.

The sutures can pass through or along the drive shafts and through oralong the curved needles, such that the sutures are guided through thenative tissue and into/adjacent to the annular prosthetic device alongwith the rotation of the curved needles. Once the sutures are guidedinto/adjacent to annular prosthetic device, the straight needles engagethe plurality of sutures and pull the sutures proximally from the curvedneedles through the annular prosthetic device.

The foregoing and other objects, features, and advantages of thedisclosure will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a distal portion of an exemplary suturing device forimplanting an annular prosthetic device within a native heart valveregion.

FIG. 2 shows the device of FIG. 1 positioned adjacent to an annularprosthetic device within a native heart valve region where the annularprosthetic device is to be sutured.

FIG. 3A shows the device of FIGS. 1 and 2 actuating to cause needles toguide several sutures simultaneously into place to secure the annularprosthetic device to the native tissue.

FIG. 3B is a detailed view of the several curved and straight needles ofthe suturing device.

FIG. 3C illustrates internal actuation components of the suturingdevice, with some exterior components shown transparent.

FIG. 4 shows the several sutures still suspended from the suturingdevice after having been guided through the native tissue and theprosthetic device, prior to suture securement.

FIG. 5 shows a perspective view of the suturing device from a distalview point.

FIG. 6 is a schematic side view of an entire suturing device including aproximal handle portion with an actuator, a shaft portion, and thedistal suturing portion.

FIG. 7 shows a perspective view of the suturing device from a proximalview point.

FIG. 8 is a plan view of the suturing portion of the device from aproximal view point, with curved needles partially deployed.

FIG. 9 is a plan view of the suturing portion of the device from aproximal view point, with curved needles fully deployed.

FIG. 10 shows an annular prosthetic device, such as an annuloplastyring, partially sutured to a native valve annulus using protectivepledgets.

FIG. 11 shows a portion of another exemplary suturing device comprisinga plurality of curved needles and configured to place several suturessimultaneously around an annular region. FIG. 11 also includes across-sectional view of the device showing one of the curved needles.

FIG. 12 is a cross-sectional side view showing the device of FIG. 12suturing a prosthetic annular device to a native valve annulus.

FIG. 13 shows an exemplary actuation mechanism for a suturing devicesimilar to that shown in FIGS. 11 and 12.

FIG. 14 is a schematic side view of a handle portion of a suturingdevice, including a trigger-based actuation mechanism.

FIG. 15 illustrates a trigger-based actuator.

FIG. 16 shows an actuator components having a helical ramp on one endand a gear on the other end.

FIG. 17 is a partially cross-sectional side view of another exemplarysuturing device for placing several sutures simultaneously using curvedand straight needles.

FIG. 18 shows an exemplary actuation mechanism in a handle portion forthe device of FIG. 17.

FIG. 19 shows another exemplary suturing device for placing severalsutures simultaneously, using an inflatable balloon.

FIG. 20 shows insertion of another exemplary suturing device through anative heart valve region.

FIG. 21 shows the device of FIG. 20 with a needle portion being deployedbelow the heart valve region, prior to retracting the device and drivingthe needles through the native tissue and a prosthetic device (notshown).

DETAILED DESCRIPTION

FIGS. 1, 2, 3A, and 4 show an annular prosthetic device 2 positioned ata desired position within the walls of a native heart valve region 4.Although the illustrated annular prosthetic device 2 is shown as atoroidal ring, it is intended to represent any of various possibleannular prosthetic devices that may be sutured in place using thedisclosed technology. In the case of implanting a prosthetic heartvalve, for example, the illustrated annular prosthetic device 2 canrepresent an outer sewing ring of the prosthetic heart valve. In otherprocedures, the illustrated annular prosthetic device 2 can represent aflat annuloplasty ring or similar devices. Similarly, although thenative heart valve region 4 is shown in FIGS. 1, 2, 3A, and 4 as acut-away ring with a cylindrical inner wall, it is intended to representthe actual geometry of a native heart valve region (e.g., aortic valveregion, pulmonary valve region, tricuspid valve region, or mitral valveregion), which includes a native valve annulus of reduced inner diameter(e.g., see FIG. 20) and may include native valve leaflets and/or othernative structures. The native leaflets and/or other native structuresmay be excised prior to implantation of the prosthetic device in manyprocedures. The prosthetic annular device is often sutured directly tothe native valve annulus (e.g., see FIG. 12), or is otherwise positionednear to the native valve annulus.

FIG. 1 shows the distal suturing portion of an exemplary suturing device10 in proximity to the annular prosthetic device 2 that is to be suturedto the native heart valve region 4. The suturing device 10 is shown invarious views in FIGS. 1-9. In FIG. 1, the suturing device 10 isdirected toward the implantation site along the axial direction of thenative heart valve, generally perpendicular to the plane of the nativevalve annulus. The annular prosthetic device 2 may be placed in thenative heart valve region 4 prior to the suturing device 10 beingintroduced, or in other embodiments the annular prosthetic device 2 canbe pre-attached to the bottom or distal end of the suturing device 10and then introduced into the native heart valve region 4 in unison. FIG.2 shows the suturing device 10 engaged with the annular prostheticdevice 2 and positioned within the native heart valve region 4 ready forthe suturing process. FIG. 3A shows an intermediate stage of thesuturing process, and FIG. 4 shows a later stage of the suturing processafter sutures can be placed through the native tissue and through theprosthetic device.

FIG. 6 shows an example of a whole suturing device 10 includingelongated shaft portions 12 and 14, and a proximal handle portion 90including a trigger actuator 92 and an actuation mechanism 94 within thehandle and causes motion of the needles and other distal components whenthe actuator trigger 92 is pressed. FIG. 6 is partially schematic, andnot necessarily drawn to scale. The shaft portion may be much longer,for example. The distal suturing portion can be inserted into thepatient to the native heart valve region, while the handle portion 90 isheld by a user outside the patient. In some examples, such a procedurecan be performed during open heart surgery. In other examples, such aprocedure can be performed a minimally invasive surgery. Access to thenative aortic valve region, for example, can be made via an incision inthe ascending aorta.

The suturing device 10 can comprise an inner shaft 12, and outer shaft14 positioned around the inner shaft, as well as straight needles 22 andcurved needles 24. The straight needles 22 can project distally from afirst support member 16. The first support member 16 can comprise adisk-shape plate, for example, with the straight needles 22 arrayedaround the perimeter of the first support member. The first supportplate 16 can be fixed relative to a collar 18, and the collar 18 can bepositioned around the distal end of the outer shaft 14. The collar 18can be engaged with the outer shaft 14 via a mechanical interface suchthat rotation of the outer shaft 14 while the inner shaft 12 remainsstationary causes axial motion of the collar 18, the support plate 18,and the straight needles 22 in unison relative to both the inner andouter shafts.

A second support member 20 that supports the curved needles 24 ispositioned distal to the first support member 16 and is coupled in afixed relationship to distal end of the inner shaft 12. When the outershaft 14 rotates relative to the inner shaft 12, the first supportmember 16 and the straight needles 22 move axially relative to thesecond support member 20. In some embodiments, the second support plate20 can include apertures that the straight needles 22 move through.

The second support member 20 supports a plurality of driver shafts 38from which the curved needles 24 extend. The drive shafts 38 can extendthrough openings in the second support member 20 that allow the driveshafts to each rotate about their own individual drive shaft axis andrestrict other motion of the drive shafts relative to the second supportmember 20. Rotation of the drive shafts 38 also causes the curvedneedles 24 to rotate about the respective drive shaft axes. Each of thedrive shafts 38 can include a proximal head 26 configured to berotationally driven by a common central driver 70. For example, theheads 26 can comprise an array of planetary gears and the common centraldriver 70 can comprise a larger diameter sun gear that is engaged withall the planetary gears at the same time. The central driver 70 can befixedly coupled to the distal end of the outer shaft 14, such thatrotation of the outer shaft 14 relative to the inner shaft 12 causes thecentral driver 70 to rotate in the same direction, which in turn causesthe heads 26, the drive shafts 38, and the curved needles 24 to rotatethe opposite direction relative to the second support member 20.

Thus, the same rotation of the outer shaft 14 relative to the innershaft 12 can cause simultaneous actuation of the straight needles andthe curved needles. Rotation of the outer shaft 14 in one directioncauses the tips of the curved needles to rotate radially outwardly anddistally (see FIG. 3A) through native tissue and then back radiallyinwardly below the annular prosthetic device 2, and simultaneouslycauses the tips of the straight needles 22 to move distally andpenetrate through the annular prosthetic device 2 to a point adjacent tothe tips of the curved needles (see FIG. 3B). Then, rotation of theouter shaft 14 in the opposite direction relative to the inner shaft 12reverses the motions of the needles, allowing hooks 34 at the tips ofthe straight needles to engage sutures 30 from the curved needles andpull the sutures back proximally through the annular prosthetic device.Looking distally from the shaft portion of the device, FIG. 8 shows thecurved needles 24 partially rotated such that the tips of the curvedneedles are at or near their maximum radial position, and FIG. 9 showsthe curved needles fully rotated around such that the curved needles arcback underneath the second support member 20.

To enable the curved needles 24 to move both radially and axially at thesame time when they rotate, the drive shafts 38 can be oriented at anon-perpendicular, non-parallel angle relative to the plane of thesecond support member 20 and the shaft axis (as shown in FIGS. 3B and3C).

As best shown in FIG. 3B, each of the drive shafts 38 can include alumen 40 extending the length of the drive shaft to guide the sutures30. The curved needles 24 can also include lumens extending from thedrive shafts 38 to near the tips of the curved needles, so that thesutures can also run through the curved needles. Near the tips, thecurved needles can include notches 36 that expose the sutures within thecurved needles. The notches allow the hooks 34 at the ends of thestraight needles to engage the sutures 30 and pull them away from thecurved needles. In some embodiments, the curved needles can also includeslits running along some or all of the length between the notch 36 andthe drive shaft lumen 40. Such slits can allow the sutures 30 to exitthe curved needles laterally after the straight needles pull the suturesaway from the notches and the curved needles are rotated back the otherdirection and retracted. As shown in FIG. 4, this can allow the a firstportion 50 of the sutures to extend from the hooks 34 of the straightneedles 22 to the annular prosthetic device 2, a second portion 54 ofthe sutures to extend from the annular prosthetic device 2 into thenative tissue 4, a third portion 52 of the sutures to extend from thenative tissue 4 into the bottom openings of the drive shaft lumens 40,and then a remaining portion of the sutures to extend through the driveshafts 38 and up through suture guide apertures 28 in the first supportmember 16 to a tensioning device (which can be part of the suturingdevice 10 or external to it). After the sutures are thusly placed, theycan be secured, such as by tying knots in the sutures or by applyingsuture securement clips or other retainers to the sutures, and free endof the sutures can be trimmed away.

FIG. 3C illustrates an exemplary mechanical interface between the collar18, the outer shaft 14, and the inner shaft 12 that converts rotationalmotion of the outer shaft into axial motion of the collar, the firstsupport member 16, and the straight needles 22. The collar 18 caninclude one or more helical grooves 60 on an inner surface of the collar(e.g., two opposing helical grooves) and the outer shaft 14 can includea corresponding one or more radial protrusions 62 that slide along thehelical grooves 60. At the same time, the outer shaft 14 can include oneor more horizontal/circumferential slots 82 and the inner shaft 12 caninclude a corresponding one or more projections 80 (or a single rodextending across the diameter of the inner and outer shafts andprojecting from both sides) that extend through the slots 82, whichrestricts the outer shaft from moving axially relative to the innershaft, while allowing the outer shaft to rotate to a limited degree (theangular width of the slots 82) relative to the inner shaft. The collar18 can also include one or more vertical grooves 84 on its inner surfacethat receive the projections 80 and permit only limited vertical motionof the collar relative to the inner shaft.

When the outer shaft 14 is rotated relative to the inner shaft 12 (e.g.,by actuation mechanism 94 in the handle portion 90, see FIG. 6), theprotrusion 62 slides along the helical groove 60 and urges the collar 18to move both axially and rotationally. However, the stationaryprojection 80 interfacing with the vertical grooves 84 in the collarprevent the collar from rotating, which forces the collar to move onlyaxially in response to the rotation of the outer shaft 14. The collar 18and the first support member 16 move axially relative to the stationarysecond support member 20 and inner shaft 12, and the straight needles 22move axially relative to the curved needles 24. At the same time, therotation of the outer shaft 14 turns the central driver gear 70, whichturns the planetary gear heads 26 on the drive shafts 38, which rotateseach of the curved needle 24. Reversing the rotational motion of theouter drive shaft 14 causes the opposite motion of the needles.

The inner shaft 12 can be hollow, allowing for any of various additionalcomponents to extend through the inner shaft from the proximal handleportion to the distal suturing portion, and optionally out of the distalend of the device. For example, lighting conduits, camera conduits,surgical tools such and cutting or expansion devices, and/or othercomponents can be positioned within the inner shaft 12.

In some embodiments, the annular prosthetic device 2 can be pre-mountedto the distal end of the suturing device 10. FIG. 2 shows an exemplaryplacement of the annular prosthetic device 2 when it is mounted on thedistal end of the suturing device 10. Additional securement and releasecomponents can be included in such embodiments to hold the prostheticdevice in place temporarily and then release the prosthetic device fromthe suturing device when desired. In some embodiments, the straightneedles 22 can be pre-inserted into and/or through the annularprosthetic device 2. The curved needles 24 can be initially positionedwithin the radial boundaries of the annular prosthetic device 2 and/orproximal to the annular prosthetic device. When the curved needles thenrotate, they can project radially outward between the second supportmember 20 and the annular prosthetic device 2 and then curl arounddistally through the tissue to a point below the annular prostheticdevice. The annular prosthetic device 2 can temporarily secured to thedistal end of the suturing device 10 via additional sutures that are cutby a cutting device of the suturing device 10, which can be mountedand/or actuated utilizing the hollow interior of the inner shaft and/orthe space below the second support member 20 and radially inside thecurved needles and drive shafts. In other embodiments, a releasableclamping mechanism can be included in the suturing device 10 that holdsand releases the annular prosthetic device 2 when desired.

FIG. 10 shows an example of an annular prosthetic device 100, in theform of an annuloplasty ring, partially sutured to a native valveannulus 102. Each suture is applied with a protective pledget 104 on oneside of the device 100. FIG. 11 illustrates a portion of anotherexemplary suturing device no that includes curved needles 118 that drivesutures 106 through the annular prosthetic device 100 and the nativeannulus 102. The device no includes a central hub 122 that can becoupled to a shaft and handle. A ring 112 is coupled to the hub 122 viaspokes. Needles drivers 114 are mounted on the ring 112. Each needledriver 114 includes a retainer 116 positioned around the ring 112 and apair of curved needles 118 projecting from the retainer 116. The needles118 can extend arcuately distally down around the ring 112 and alsocircumferentially around the hub 122 (e.g., counter-clockwise in FIG.11). Each needle driver 114 can include a tab 120 that extends from theretainer 116 and is coupled to an actuation mechanism (e.g., see FIG.13) that causes the needle drivers and curved needles to rotate inunison about the ring 112. The entire ring 112 can also spin about thecentral hub 122 at the same time as the needle drivers rotate to causethe needles to move circumferentially as well as the rotation motionabout the ring. The needles 118 can be hollow and guide suture strandsinside the needles through the prosthetic and the annulus when theneedle drives rotate. The two suture strands in adjacent needles of oneneedle driver can form a loop that is premounted with a pledget 104, sothat when the two free ends are pulled tight, the pledget 104 moves intothe position shown in FIG. 10.

FIG. 12 shows another exemplary suturing device 200 similar to thedevice 110. The device 200 includes ring 212 with curved needles 218,needle retainers 216, and tabs 220 similar to the device no. Inaddition, the device 200 can include straight needles 232 that moveaxially and cooperate with the curved needles to guide sutures throughthe native annulus 204 and through an annular prosthetic device 230positioned above the annulus. The curved needles and straight needlescan actuate similar to the suturing device 10, where the curved needlesinitially guide the sutures through the native tissue and then thestraight needles pull the sutures up through the annular prostheticdevice. FIG. 13 shows an actuation mechanism for the suturing device200. Shaft 226 moves axially and pushes and pulls plate 224, which iscoupled to each of the tabs 220 for the several needle drivers viavertical linkages 222. When the shaft 226 moves up, the curved needles218 rotate outwardly and downwardly, and when the shaft 226 moves down,the curved needles retract back up and in. The axial motion of the shaft226 can be coordinated with the reverse axial motion of the straightneedles 218, such that the straight and curved needles meet at thebottom below the annulus 204 for the straight needles to grab and pullthe sutures from the curved needles.

FIG. 14 shows an exemplary proximal portion 300 that can be used withany of the disclosed suturing devices. The proximal portion 300 includesa handle 302 and a shaft portion 304. A trigger 306 is pulled by a userto actuate the suturing device. As shown in FIGS. 15 and 16, the trigger306 can have a shaft 308 with an inclined surface that interfaces with ahelical surface of a shaft 310 fixed to a first gear 312. Pulling thetrigger causes the first gear 312 to rotate. The first gear 312 drives asecond gear 314, which rotates a drive shaft 316 within a fixed outershaft 320. The drive shaft 316/318 can drive the actuation of the distalsuturing portion of the device.

FIGS. 17 and 18 illustrate another exemplary suturing device 406comprising a proximal portion 400 (FIG. 18) with a handle 402 and shaftportion 404 coupled to the distal suturing portion (FIG. 17). The handleportion includes trigger 410 that is pulled proximally to move an innershaft 420 and a first rack 412 proximally. The first rack 412 turns apinion gear 414 that in turn moves a second rack 416 distally. Thesecond rack 416 pushes an outer shaft 418 distally. As shown in FIG. 17,the inner shaft 420 is coupled to a linkages 430, 432, and 434 thatrotate the curved needles 436. The outer shaft 418 is coupled to a driveplate 422 that drives the straight needles 428 axially at the same timeas the curved needles rotate. The stationary handle portion 400 can befixed relative to distal plate 426 that supports the curved needlemechanism, similar to the suturing device 10.

FIG. 19 shows another exemplary suturing device 500. The device 500comprises an outer shaft 502, an inner shaft 504, a proximal end 506that can be coupled to a proximal portion of the device (not shown), adistal end 508 of the device, an inflatable balloon 510, plural needles520 mounted around the perimeter of the balloon, and one or more sutures530 extending through the outer shaft 502, out the distal end 508, andengaged on distal hooks 524 of the needles 520. The suture 530 formsloops between the hooks 524 with a pledget optionally included on eachof the suture loops. Although not shown, an annular prosthetic devicecan be included around the outer shaft 502 proximal to the needles 520.Alternatively, the annular prosthetic device can be pre-positioned inthe desired implantation site above the annulus and then the device 500can be inserted through both the prosthetic and the annulus.

The balloon 510 can be initially deflated when the device 500 isinserted through a native valve annulus. Once the needles 520 havecleared the annulus and the annular prosthetic device is in the desiredposition above the annulus, the balloon 510 can be inflated by fluidpumped through the inner shaft 504 from a proximal source. Inflationcauses the needles 520 to expand radially apart to a desired arrayformation under the annulus. With the needles 520 in the desiredposition, the device can retracted proximally to drive points 522 of theneedles through the annulus and through the annular prosthetic deviceabove the annulus. Then, the balloon can be deflated and the needlesdetached from the balloon. Each needle can then be pulled all the wayproximally through the annulus and prosthetic, pulling the sutures 530up through the annulus and prosthetic along with the needles, andpositioning the pledges below the annulus to prevent sutures pullingthrough the tissue.

FIGS. 20 and 21 illustrate another exemplary suturing device 600comprising an inner shaft 602, an outer shaft 604, a grip 606 on theouter shaft, a distal head 608 coupled to the distal end of the innershaft at the distal end of the outer shaft, and a proximal portion 610coupled to the proximal end of the inner shaft. As shown in FIG. 20, thedistal head 608 can initially be inserted through a native valve annulus630. As shown in FIG. 21, the grip 606 can then be used to retract theouter shaft 604, which exposes an array of needles 620 that extendproximally from adjacent the distal head 608. The needles 620 canresiliently pop radially outwardly to a preset functional positionmatching the size of the annulus 630. The device 600 can then by pullback proximally to drive the needles 620 through the annulus in unison.An annular prosthetic device can be positioned on the proximal side ofthe annulus and the needles 620 can be driven through the prostheticdevice after passing through the annulus. Each needle 620 can guide asuture (e.g., within hollows inside the needles) through the annulus andthrough he prosthetic. The other end of the sutures can run up throughthe inner shaft to the proximal portion 610 of the device.

In any of the disclosed suturing device embodiments, the total number ofcurved needles and/or straight needles can vary according to thesuturing needs of the given prosthetic device. In some cases, just a twoor three or four sutures may be sufficient, and thus just many of eachof needles may be included in the suturing device. For larger, morerobust prosthetic devices, such as a prosthetic aortic valve for a largeman, 10, 12, 14, 16, 18, 20 or more sutures may be needed to secure thedevice to the native tissue, and a corresponding number of each type ofneedles can be included in the suturing device. The can be the samenumber of curved needles as the straight needles, so that they arearranged in pairs of one of each kind of needle for each suture. Theneedles can be arrayed around the suturing device in a shape thatmatches the shape of the native structure and/or the prosthetic device,such as a circular array, an oval-shaped array, a D-shaped array, akidney-shaped array, a C-shaped array, etc. In some embodiment theprosthetic device can be only partially annular, such as a C-shapedannuloplasty ring, (such embodiments are still considered “annularprosthetic devices” as that term is used herein) and the needles of thesuturing device can be arrayed in a correspondingly similarconfiguration.

Some embodiments that fall within the scope of the disclosed technologyinclude needles that are oriented and/or move in directions generallyreverse of the embodiments disclosed in the figures and above. Forexample, in such embodiments, the curved needles can curveupwardly/proximally when penetrating through the native tissue, ratherthan downwardly/distally. The straight needles (if included) may alsomove proximally first to penetrate the annular prosthetic device, andthen retract back distally. By reversing the needle motion, the devicecan suture a prosthetic device in place from the opposite side of thenative valve annulus. For example, an annular prosthetic device can besutured to an inferior/distal side of an aortic valve annulus with thesuturing tool still be deployed from the superior/proximal side. Forexample, the suturing device and prosthetic device can pass distallythrough the native valve orifice first before suturing in suchembodiments, then with the prosthetic device in place, the curvedneedles can be deployed to penetrate up/proximally through the nativetissue. The straight needles, if included, can project up/proximallyfrom a plate on the suturing device and can pass upwardly/proximallythrough the prostetic device (e.g., a sewing ring) to meet with the tipsof the curved needles to engage the sutures on the proximal side thedevice and pull the sutures back down distally through the prostheticdevice.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallymay in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods.

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Further, the term “coupled” generally means physically, mechanically,chemically, magnetically, or otherwise linked and does not exclude thepresence of intermediate elements between the coupled or associateditems absent specific contrary language.

As used herein, the term “proximal” refers to a position, direction, orportion of a device that is closer to the user and further away from theimplantation site. As used herein, the term “distal” refers to aposition, direction, or portion of a device that is further away fromthe user and closer to the implantation site. Thus, for example,proximal motion of a device is motion of the device away from theimplantation site and toward the user (e.g., out of the patient's body),while distal motion of the device is motion of the device away from theuser and toward the implantation site (e.g., into the patient's body).The terms “longitudinal” and “axial” refer to an axis extending in theproximal and distal directions, unless otherwise expressly defined. Inthe context of the present application, the terms “lower” and “upper”are used interchangeably with the terms “proximal” and “distally”,respectively. Thus, for example, the lower or bottom side of a device isits distal side and the upper or top side of the device is its proximalside.

In view of the many possible embodiments to which the principles of thedisclosure may be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather, the scope of thedisclosure is at least as broad as the following claims. We thereforeclaim all that falls within the scope and spirit of these claims.

1. A suturing device for suturing a prosthetic device within a nativeheart valve region, the device comprising: a shaft portion defining ashaft axis; an actuator coupled to the shaft portion; and a suturingportion coupled to the shaft portion, the suturing portion includingcurved needles disposed around the shaft axis and straight needlesdisposed around the shaft axis; wherein the straight needles and thecurved needles are configured to place a plurality of sutures; andwherein the actuator causes the straight needles and the curved needlesto move relative to the shaft portion, such that the motions of thestraight needles and the curved needles are coordinated to place theplurality of sutures that secure the prosthetic device within the nativeheart valve region.
 2. The suturing device of claim 1, wherein theprosthetic device comprises a prosthetic heart valve.
 3. The suturingdevice of claim 1, wherein the prosthetic device comprises anannuloplasty ring.
 4. The suturing device of claim 1, wherein the nativeheart valve region is a native aortic valve region.
 5. The suturingdevice of claim 1, wherein the straight needles project distally from afirst rigid support plate of the suturing portion.
 6. The suturingdevice of claim 1, wherein the straight needles comprise hooks at theirdistal ends.
 7. The suturing device of claim 1, wherein the straightneedles penetrate the prosthetic device when the actuator causes thestraight needles to move relative to the shaft portion.
 8. The suturingdevice of claim 1, wherein the curved needles each project from arespective drive shaft of the suturing portion, and the curved needleseach rotate about an axis of their respective drive shaft.
 9. Thesuturing device of claim 8, wherein the drive shafts are all supportedby a second rigid plate of the suturing portion, such that the driveshafts can each rotate about their respective axis relative to thesecond rigid plate.
 10. The suturing device of claim 9, wherein thestraight needles pass through openings in the second rigid plate. 11.The suturing device of claim 8, wherein the drive shafts are all engagedto a common central driver of the suturing portion, wherein the centraldriver causes the drive shafts and the curved needles to rotate.
 12. Thesuturing device of claim 8, wherein the plurality of sutures passthrough the drive shafts and through the curved needles.
 13. Thesuturing device of claim 1, wherein the curved needles guide theplurality of sutures through tissue in the native heart valve region andadjacent to the prosthetic device when the curved needles move.
 14. Thesuturing device of claim 1, wherein the straight needles engage theplurality of sutures and pull the sutures proximally from the curvedneedles through the prosthetic device.
 15. The suturing device of claim1, wherein the curved needles are configured to guide sutures proximallythrough the native tissue as they rotate.
 16. A suturing device forsuturing a prosthetic device within a native heart valve region, thedevice comprising: a shaft portion defining a shaft axis; and a suturingportion coupled to the shaft portion, the suturing portion includingcurved needles disposed around the shaft axis and straight needlesdisposed around the shaft axis; wherein the straight needles moveaxially and the curved needles to move rotationally, such that themovements of the straight needles and the curved needles are coordinatedto simultaneously place the plurality of sutures that secure theprosthetic device within the native heart valve region.
 17. The suturingdevice of claim 16, wherein the straight needles penetrate theprosthetic device when the straight needles move axially, and thestraight needles engage the plurality of sutures and pull the suturesproximally from the curved needles through the prosthetic device. 18.The suturing device of claim 16, wherein the curved needles each projectfrom a respective drive shaft of the suturing portion, and the curvedneedles each rotate about an axis of their respective drive shaft. 19.The suturing device of claim 18, wherein the drive shafts are allengaged to a common central driver of the suturing portion, wherein thecentral driver causes the drive shafts and the curved needles to rotate.20. The suturing device of claim 18, wherein the plurality of suturespass through the drive shafts and through the curved needles, andwherein the curved needles guide the plurality of sutures through tissuein the native heart valve region and adjacent to the prosthetic devicewhen the curved needles move.